Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+Z: A-SOC: 4Bdq(Lzd)+Lfx(Mfx)+Cfz(Cs)+Pto+E+H+Z/5Lfx(Mfx)+Cfz(Cs)+E+Z During the intensive phase: Bedaquiline(Linezolid);Levofloxacin(Moxifloxacin) All treatment is taken orally
A1: 9Bdq(6m)+Fq+Lzd+Cs+Cfz
A2a: 9Bdq(6m)+Fq+Lzd(600mg)+Cs+Z
A2b: 9Bdq(6m)+Fq+Lzd(2m)+Cs+Z
A2c: 9Bdq(6m)+Fq+Lzd(600mg-300mg)+Cs+Z
A3: 9Bdq(6m)+Fq+Lzd+Cfz+Z
A4: 9Bdq(6m)+Fq+Cfz+Cs+Z
A5: 9Fq+Lzd+Cfz+Cs+Z
B-SOC: 6Bdq+Lzd+Cs+Cfz/14Lzd+Cfz+Cs
B1: 9Bdq(6m)+Lzd+Cs+Cfz+Z
Study summary
The INSPIRE-TB study is a pragmatic, multicentre, randomised, controlled, non-inferiority open-label trial to evaluate the efficacy and safety of seven 9-month oral regimens compared to a 9-month standard of care (SOC) regimen in RR-TB participants susceptible to fluoroquinolones, and a bedaquiline-containing 9-month oral regimen compared to a 20-month conventional regimen in RR-TB participants resistant to fluoroquinolones
Eligibility
Sex
ALL
Min age
16 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Male or female patients aged 16-75 years with weight over 30kg, regardless of HIV status;
2. Pulmonary TB with rifampicin resistance diagnosed with either WHO-approved rapid molecular diagnostic test or phenotype drug susceptibility test (within 60 days prior to randomisation) ;
3. Signed informed consent form (ICF).
Exclusion Criteria:
1. Known allergies, hypersensitivity, or contraindication to any of the study drugs as described in additional material;
2. Participants combined with central nervous system TB, tuberculous osteomyelitis or arthritis, hematogenous disseminated pulmonary TB;
3. Patients known to be pregnant or breastfeeding at the time of enrollment;
4. Patients who have received second-line MDR-TB treatment for 14 days or more prior to enrollment;
5. Patients in critical condition and expected survival is estimated by physician to be less than 12 weeks.
Primary outcome measure(s)
a favorable outcome at the end of study — at 21 months after randomization A favorable outcome is defined by the absence of previous unfavorable, and the last two culture results are negative. These two cultures must be taken from respiratory samples collected on separate visits at least 7 days apart. The latest culture sample should be collected between month 21 and 23.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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